Cleared Traditional

K864891 - API UNISCEPT (TM) KB

K864891 is an FDA 510(k) clearance for API UNISCEPT (TM) KB, manufactured by Analytical Products, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K864891 · Analytical Products, Inc. · Microbiology device
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Feb 1987
Decision
67d
Days
Class 2
Risk

K864891 is an FDA 510(k) clearance for the API UNISCEPT (TM) KB. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on February 20, 1987 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Analytical Products, Inc. devices

FDA 510(k) Submission Details - K864891

510(k) Number K864891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1986
Decision Date February 20, 1987
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 394
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K864891.
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1987
SENSIR SYSTEM
K870719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC
K870663 · Analytical Products, Inc. · Mar 1987
MICRODILUTION MIC PANELS
K863776 · American Micro Scan · Feb 1987
REVISED RESISTANT 5 MIC PANEL
K864493 · Pasco Laboratories, Inc. · Feb 1987
PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID
K864069 · Austin Biological Laboratories · Nov 1986